MAUDE Adverse Event Report: COVIDIEN PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD; CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	PRB35-08-040-120
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was using a protégé everflex for treatment.No abnormalities were noted in relation to patient anatomy.No issues were noted during prep.It is reported that following deployment of the stent when the physician was removing the device, the inner sheath came apart from the device and was almost left in the patient.No additional interventions were needed to remove the sheath.No patient injury was reported.Case was completed without difficulty.
Additional Manufacturer Narrative
The protégé everflex self-expanding peripheral stent system was received for evaluation.No ancillary devices or cine images from the procedure were received.The protégé everflex stent delivery system was received in two segments: deployment paddles, stainless-steel hypotube, manifold with outer sheath, and inner assembly with distal tip, and with the safety locking tight.The inner assembly with distal tip was examined.Sanguine residue/fluid was noted within the guidewire lumen of the inner assembly.No kinks in the inner assembly were noted.The proximal end of the inner assembly was examined under magnification.The separation face at the proximal end of the inner assembly was in the area of the 3-in-1 bond.The separation face exhibits tensile force stretching.The segment consisting of the deployment paddles, stainless-steel hypotube, manifold and outer sheath was examined.A series of kinks in the outer sheath were noted at approximately 82.9cm, 112.1cm and 115cm proximal of the distal end of the outer sheath.Clear fluid was noted within the stopcock tubing of the manifold.Sanguine residue was noted within the proximal luer lock hub.The stainless-steel hypotube and proximal deployment paddle were removed from the manifold to allow further examination.The 3-in-1 bond attached to the stainless-steel hypotube exhibited tensile force separation face.When compared to the inner separation face the stainless-steel hypotube separation face matched up.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7713293
• Report Number: 2183870-2018-00391
• Device Sequence Number: 16476199
• Product Code: FGE
• UDI-Device Identifier: 00821684069509
• UDI-Public: 00821684069509
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K060057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/15/2020
• Device Catalogue Number: PRB35-08-040-120
• Device Lot Number: A509044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 07/25/2018; 08/08/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 08/20/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1